FDA notes that it “identified 62 cases of complex sleep behaviors that resulted in serious injuries or death after taking insomnia medicines eszopiclone, zaleplon, or zolpidem reported in the FDA Adverse Event Reporting System (FAERS) database between December 16, 1992, and February 27, 2018, and four additional cases reported in the medical literature1-5 between December […]
Well, for us old folks, change is always something that makes us queasy. The newly-designed FDA website stirred those feeling all over again as we try to navigate the new links and find the information that was once at our fingertips (or at least in our bookmarks). There were some wrong turns and some dead […]
OGD posted an update of its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) for March 2019. As a mirror image of last month, OGD refused-to-receive (RTR) six (6) ANDAs, four (4) of which were standard review, and two (2) were for priority review applications. OGD sent 95 acknowledgement letters for […]
With four reporting days remaining in April, the Office of Generic Drugs has issued full approval actions on sixty-nine ANDAs and tentative approval actions on thirteen ANDAs for a total of eighty-two approval actions. We remind our readers of the potential difference from actual individual ANDA approvals or actual individual ANDA tentative approvals based on […]
Back in 2016, FDA indicated that it was planning to issue a guidance document to explain to firms how to extend expiration dating for doxycycline tablets and capsules held in national stockpiles (here) . Doxycycline is stored in national stockpiles for treatment of post-exposure prophylaxis (PEP) or treatment of inhalational anthrax in the event of […]
In an immediately effective guidance document entitled Compliance Policy for Combination Product Postmarketing Safety Reporting (here), the FDA is announcing that it will exercise enforcement discretion for certain safety reporting requirements outlined in the Combination Product Postmarketing Safety Reporting Final Rule issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR […]
As I was reviewing the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) as I do a few times a month, I came across a new footnote to the report. It reads: ++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by […]
Publishing tomorrow, the FDA will announce that 28 ingredients that were considered in the June 30, 2016 proposed rule were given the boot while further consideration of three ingredients (benzalkonium chloride, alcohol (also referred to as ethanol or ethyl alcohol), and isopropyl alcohol) were deferred until the firms had more time to conduct appropriate studies […]
As always, Lachman Consultants looks to provide excellence in all phases of serving our clients’ needs, so we paid close attention to the various speakers, panels and general goings-on at the 2019 ISPE Europe meeting to take the pulse of the industry. We also spoke to many of the show’s attendees, and the takeaways from […]
March 2019 actually saw 89 full approvals and 17 tentative approvals for 106 approval actions (our predictions were off by one). This is another good month for ANDA approvals, but it is also a month that saw the largest number of ANDA submission for FY 2019 at 118. We believe this corresponds to the end […]
